Edge Computing Platform for Spine Health Risk Management Based on IoT Technology

July 9, 2025 updated by: Xuanwu Hospital, Beijing
This project proposes to monitor the spinal posture of a person at rest and in motion in real time through a sensor device that contains spinal health monitoring as its core. By calibrating the five core planes on the spine and using AI algorithms to train the model, the relationship between the core plane data and spine health is established.This project will output medical-grade and consumer-grade wearable spine healthcare and monitoring products, establish an interactive platform to connect the wearer, the data terminal and the professional medical team, so that patients can easily get professional health advice and reminders during home healthcare and rehabilitation; and through the collection of spine health data, establish a national spine health database.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Edge Computing Platform for Spine Health Risk Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 18 and 60 years.
  • Degenerative diseases of the cervical spine such as cervical disc herniation, cervical stenosis, ossification of the posterior longitudinal ligament, etc., but surgery is not considered for the time being.
  • Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.

Exclusion Criteria:

  • Age less than 18 years or more than 60 years.
  • Life expectancy less than 1 year.
  • Suffering from severe dementia (MMSE score less than 18).
  • Suffering from other serious medical conditions.
  • Inability to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wearable Device Group
The Wearable Device Group uses wearable devices to perform rehabilitation exercises using the provided strategies. It includes the application of IoT technology to build a cloud platform combining software and hardware, using the spine sensors described in this project to collect behavioral data (it is recommended that they be worn during working hours every day for no less than 7 hours/week), and using end-to-end AI algorithms for health monitoring; the visualized data is synchronized to the spine health platform for real-time viewing and analysis by both doctors and patients. Through cell phone software and internet platform, spine health files are established to realize convenient and efficient communication between patients and professional doctors.
Device: Wearable Device
Whether to use wearable devices.
No Intervention: Traditional group
The Traditional intervention group used traditional interventions, i.e., routine patient education, guidance on rehabilitation exercises, and tips on proper lifestyle habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: Enrollment baseline，the first month, the second month, the third month
Evaluate the efficacy of the device in reducing patients' pain. A score of 0 indicates no pain and a score of 10 represents the most severe pain that is unbearable.
Enrollment baseline，the first month, the second month, the third month
neck disability index
Time Frame: Enrollment baseline，the first month, the second month, the third month
The NDI consists of 10 items, including two parts: neck pain and related symptoms and activities of daily living. Each item has a minimum score of 0 and a maximum score of 5, with higher scores indicating more severe dysfunction.
Enrollment baseline，the first month, the second month, the third month
quality of life short form 12
Time Frame: Enrollment baseline，the first month, the second month, the third month
Evaluate the efficacy of the device in improving patients' quality of life.The maximum value of physical score is 56.58 and the maximum value of mental score is 60.76. A higher score indicates a better quality of life.
Enrollment baseline，the first month, the second month, the third month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle strength (grade)
Time Frame: Enrollment baseline, the third month

Change in muscle strength (grade) = Muscle strength at the third month - Muscle strength at enrollment.

Muscle strength is graded from 0 to 5, with higher grades indicating better motor function of the extremities.

Muscle strength is evaluated by experienced physicians.
Enrollment baseline, the third month
Change in muscle tone (grade)
Time Frame: Enrollment baseline, the third month

Change in muscle tone (grade) = Muscle tone at enrollment -Muscle tone at the third month.

Muscle tone is graded into 6 grades, with higher grades indicating worse motor function of the extremities.

Muscle tone is evaluated by experienced physicians.
Enrollment baseline, the third month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XW-NS-NECKBRACE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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